Biotech Mailbag: Cel-Sci, BioElectronics

Helping the process along has been unintentionally hilarious, yet incredibly misleading articles about Cel-Sci flu vaccine/drug research from web sites specializing in penny stock promotion. My favorite of these nonsense articles can be read here.

Returning to reality, the government is buying a lot of vaccines and drugs against H1N1, but they're not buying it from Cel-Sci, which has no real data to show that its vaccine works at all, let alone better than the currently approved H1N1 medicines. A mountain of press releases doesn't count as evidence.

Returning to Multikine, this "next generation" cancer immunotherapy has been sitting in phase II limbo for years. The start of a promised phase III study is always right around the corner but never seems to happen.

Perhaps that's because the phase II data on Multikine in head-and-neck cancer patients isn't very convincing. The study, published in the Journal of Clinical Oncology in 2005, enrolled just 19 patients with head-and-neck cancer and treated them with Multikine prior to surgery. The study concludes that treatment with Multikine resulted in a 21% objective response rate. Yet the study lacks a proper control arm, rendering the outcome rather meaningless.

Cel-Sci claimed in follow-on analyses of the study that Multikine led to a significant increase in survival for these patients, but again, compared to what? Historical controls? Sorry, but you can't make credible survival claims in a study that lacks a proper control arm.

Cel-Sci's boosters point to Dendreon's(DNDN) prostate cancer vaccine Provenge as proof that cancer can be treated successfully through priming of a patient's immune system. Therefore, if Provenge works, so will Multikine.